Learning From Experience: A Systematic Review of Community Consultation Acceptance Data

doi:10.1016/j.annemergmed.2014.06.023

Annals of Emergency Medicine

Volume 65, Issue 2, February 2015, Pages 162-171.e3

https://doi.org/10.1016/j.annemergmed.2014.06.023 Get rights and content

Study objective

Federal regulations permitting an exception from informed consent for research in emergency settings require community consultation before study approval. Rates of acceptance of exception from informed consent in community consultation are often reported, but predictors of acceptance are not well understood, and investigators and institutional review boards struggle to interpret and use acceptance data.

Methods

We systematically reviewed empirical literature on community consultation for exception from informed consent trials in the PubMed, EMBASE, and Web of Science databases. We included peer-reviewed articles reporting acceptance data from community consultation for US exception from informed consent trials. Questions were categorized by enrollment focus (eg, personal enrollment versus more general exception from informed consent acceptance), and observed acceptance was compared across studies. We also compared potential predictors of acceptance, including demographic factors, consultation method, and target community.

Results

Nine studies (total n=9,036 participants) were included in the final analysis. Personal acceptance of enrollment in the proposed exception from informed consent study ranged from 45% to 93% and clustered in the range of 64% to 80%. Acceptance of the exception from informed consent mechanism in general (without reference to personal inclusion) was lower (35% to 84%) than personal acceptance. The effect of demographic characteristics on acceptance was inconsistent, and meeting-based consultation methods were associated with greater acceptance than survey-based methods. Finally, acceptance rates varied substantially according to the phrasing of the question.

Conclusion

Personal acceptance clustered between 64% and 80%. This range may be informative for institutional review boards and investigators evaluating community consultation results. However, numerous factors affect acceptance, and there is a need for considerable caution against overreliance on acceptance data.

Introduction

Regulations permitting an exception from informed consent have facilitated an increasing number of pivotal clinical trials across a range of emergency cardiovascular, neurologic, and traumatic conditions. Although experience and comfort with exception from informed consent has increased among investigators, institutional review boards, and regulators, the requirement that investigators consult communities before approval and initiation of a proposed trial continues to pose challenges.1, 2 This is not surprising, especially because community consultation is not required by regulation for any other form of research.2, 3

Editor’s Capsule Summary

What is already known on this topic

An increasing number of studies in the emergency department setting involve exception from informed consent.

What question this study addressed

How do investigators measure community acceptance of exception from informed consent research?

What this study adds to our knowledge

Community acceptance rates vary widely and are difficult to interpret because the process of involving communities and gauging their support of exception from informed consent research is underdeveloped.

How this is relevant to clinical practice

As we strive toward more patient-centered care, we must learn how to successfully engage and attain community support for research on the care of urgently ill patients.

Food and Drug Administration guidance enumerates 4 principal goals of community consultation: (1) to show respect for persons by informing the community in advance; (2) to inform community members in advance and facilitate meaningful input to the institutional review board; (3) to show respect for the community through allowing community members to identify potential concerns; and (4) to show respect for autonomy, particularly by inclusion of individuals expected to be similar to enrolled subjects.³ Other proposed goals in the literature include fostering trust and sharing responsibility with the community.3, 4, 5, 6 Although these goals are laudable, putting them into operation and prioritizing among them has been challenging.

One problem has been to ascertain the proper role of community consultation feedback in approval decisions. Food and Drug Administration guidance explicitly distinguishes community consultation from community consent, and the regulations do not require quantifying community acceptance.³ However, quantitatively assessing community acceptance has been a focus of many consultation efforts, and analogies have been drawn between community consultation and democratic decisionmaking.⁷ Knowing what to do with acceptance data can be difficult for investigators and institutional review boards, and it is unknown how many studies have been altered or disapproved in accordance with community consultation feedback. One investigator described a decision not to pursue a trial of a blood substitute study after community consultation alerted the team to the high local prevalence of Jehovah’s Witnesses.⁸ However, a survey of institutional review board chairs at US medical schools reported no rejections of exception from informed consent trials because of unfavorable community feedback.⁹ No consensus exists about what levels of disagreement are problematic.

In addition to questions about appropriate levels of acceptance, interpreting acceptance data is made more challenging by the existence of highly divergent consultation practices striking different balances between population representation and interaction with consultants. These methods range from detailed interviews with stakeholders to large population-based surveys. These methods prioritize different goals, facilitate different kinds of feedback, and appear to affect consultants’ attitudes toward proposed exception from informed consent trials.10, 11, 12

A body of literature has emerged reporting the results of community consultation for exception from informed consent research since passage of the exception from informed consent regulations in 1996. Acceptance data are the focus of many of these reports. We conducted a systematic review of this literature to clarify reported ranges of acceptance, identify potential predictors of acceptance, and clarify areas for further study. A major goal was to identify trends that may aid investigators and institutional review boards in designing consultation efforts and interpreting their results.

Section snippets

Objective

The objective of this study was to systematically review published community consultation data to address several key questions about acceptance. First, what is the range of reported acceptance among community consultation participants, and can any benchmark or baseline levels of acceptance be identified? Second, are there consistent predictors of acceptance related to the way consultation is conducted; specifically, phrasing and content of questions and consultation method used? Third, are

General Results

The original search identified 510 articles; 37 were reviewed in full (Figure 1). Two articles that otherwise met selection criteria were excluded: one was published in abstract form only and did not include assessment questions; the other was a qualitative study that did not describe specific assessment questions or numerically report acceptance.16, 17 Nine articles were included in the final analysis.

Measured Attitudes Toward Exception From Informed Consent

Three types of questions predominated about attitudes toward exception from informed consent:

Limitations

This study was limited by availability of published data. It is unknown whether acceptance in unpublished reports would be systematically different. Additionally, this study is not a meta-analysis. Though descriptive quantitative cross-study comparisons were possible in some domains, only qualitative comparisons were possible in others.

Several specific limitations also warrant mention. First, there was heterogeneity in question phrasing. A strength of this review is its ability to examine

Discussion

This review provides insights into community consultation for exception from informed consent research conducted since passage of the exception from informed consent regulations. Some findings have important practical implications that may help investigators, institutional review boards, and regulators to design, conduct, and interpret activities. Other findings clarify a research agenda that may further refine understanding of the role of and need for community consultation in this context.

One

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Cited by (26)

Community consultation in the pediatric intensive care unit for an exception from informed consent Trial: A survey of patient caregivers
2023, Resuscitation Plus
To explore perspectives of families in the pediatric intensive care unit (PICU) about an emergency interventional trial on peri-arrest bolus epinephrine for acute hypotension using Exception From Informed Consent (EFIC).
We performed face-to-face interviews with families whose children were hospitalized in the PICU. A research team member provided an educational presentation about the planned trial and administered a survey with open- and closed-ended items. Analyses included descriptive statistics for quantitative data and thematic analysis for qualitative data.
Sixty-seven participants contributed to 60 survey responses (53 individuals and 7 families for whom 2 family members participated). Most participants answered favorably toward the planned trial: 55/58 (95%) reported that the trial seemed “somewhat” or “very important”; 52/57 (91%) felt the use of EFIC was “somewhat” or “completely acceptable”; and 43/58 (74%) said they would be “somewhat” or “very likely” to allow their child to participate. Five themes emerged supporting participation in the planned trial: 1) trust in the clinical team; 2) familiarity with the study intervention (epinephrine); 3) study protocol being similar to standard care; 4) informed consent during an emergency was not feasible; and 5) importance of research. Barriers to potential participation included requests for additional time to decide about participating and misconceptions about study elements, especially eligibility.
Families of PICU patients generally supported plans for an emergency interventional trial using EFIC. Future inpatient EFIC studies may benefit from highlighting the themes identified here in their educational materials.
Community consultation for Exception from Informed consent (EFIC) before and during the COVID-19 pandemic
2022, Resuscitation Plus
Describe community consultation and surrogate consent rates for two Exception From Informed Consent (EFIC) trials for out-of-hospital cardiac arrest (OOHCA) - before and during the COVID-19 pandemic.
The PEARL study (2016–2018) randomized OOHCA patients without ST-elevation to early cardiac catheterization or not. Community consultation included flyers, radio announcements, newspaper advertisements, mailings, and in-person surveys at basketball games and ED waiting rooms. The PROTECT trial (2021-present) randomizes OOHCA survivors to prophylactic ceftriaxone or placebo; the community consultation plan during the pandemic included city council presentations, social media posts, outpatient flyers, but no in-person encounters. Demographics for PROTECT community consultation were compared to PEARL and INTCAR registry data, with p-value < 0.05 considered significant.
PEARL surveyed 1,362 adults, including 64 % ≥60 years old, 96 % high school graduates or beyond; research acceptance rate was 92 % for the community and 76 % for personal level. PROTECT initially obtained 221 surveys from electronic media – including fewer males (28 % vs 72 %,p < 0.001) and those > 60 years old (14 % vs 53 %;p < 0.001) compared to INTCAR. These differences prompted a revised community consultation plan, targeting 79 adult in-patients with cardiac disease which better matched PEARL and INTCAR data: the majority were ≥ 60 years old (66 %) and male (54 %). Both PEARL and PROTECT enrolled more patients using surrogate consent vs EFIC (57 %, 61 %), including 71 % as remote electronic consents during PROTECT.
Community consultation for EFIC studies changed with the COVID-19 pandemic, resulting in different demographic patterns. We describe effective adaptations to community consultation and surrogate consent during the pandemic.
European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions
2021, Resuscitation
Citation Excerpt :
In contrast, a strict requirement for pre-enrolment consent may delay the initiation of an experimental intervention, thereby hampering its potential benefit to the patient.327 Another ethically acceptable and legally supported consent model comprises exception to informed consent (EIC) with prior community consultation (and a possibility of prospective opt out for community members).328–335 The EIC model also mandates obtaining post-enrolment consent.317
These European Resuscitation Council Ethics guidelines provide evidence-based recommendations for the ethical, routine practice of resuscitation and end-of-life care of adults and children. The guideline primarily focus on major ethical practice interventions (i.e. advance directives, advance care planning, and shared decision making), decision making regarding resuscitation, education, and research. These areas are tightly related to the application of the principles of bioethics in the practice of resuscitation and end-of-life care.
Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke
2020, The Lancet Neurology
Citation Excerpt :
It remains unclear whether patients, proxies, health-care providers, administrators, or a general population should be considered to be the community.63 Although some reports are positive and participants satisfied,64,65 community consultation and public disclosure are also challenging, time consuming, and costly.66,67 A study68 reviewed 28 completed and published acute care studies between 1996 and 2018, that used exception from informed consent or waiver of informed consent.68
Health-care professionals and researchers have a legal and ethical responsibility to inform patients before carrying out diagnostic tests or treatment interventions as part of a clinical study. Interventional research in emergency situations can involve patients with some degree of acute cognitive impairment, as is regularly the case in traumatic brain injury and ischaemic stroke. These patients or their proxies are often unable to provide informed consent within narrow therapeutic time windows. International regulations and national laws are criticised for being inconclusive or restrictive in providing solutions. Currently accepted consent alternatives are deferred consent, exception from consent, or waiver of consent. However, these alternatives appear under-utilised despite being ethically permissible, socially acceptable, and regulatorily compliant. We anticipate that, when the requirements for medical urgency are properly balanced with legal and ethical conduct, the increased use of these alternatives has the potential to improve the efficiency and quality of future emergency interventional studies in patients with an inability to provide informed consent.
Patient and Surrogate Postenrollment Perspectives on Research Using the Exception From Informed Consent: An Integrated Survey
2020, Annals of Emergency Medicine
Citation Excerpt :
These data help to confirm that previous estimates of patients’ and surrogates’ perceptions of exception from informed consent enrollment appear to be accurate. General acceptance of enrollment in ESETT was approximately 90% and was similar to rates reported in previous smaller studies embedded within other exception from informed consent trials and estimates from community consultation efforts.7,10,11 This largely favorable reaction is encouraging and important.
It is important for researchers interested in trials using the exception from informed consent to understand the views and experiences of enrolled individuals. Previous studies have shown that patient and surrogate attitudes are generally positive. These studies were small and did not include pediatric patients, and interviews were often conducted long after trial enrollment. This study sought to explore attitudes toward exception from informed consent in a larger sample and more contemporaneous setting.
A 10-item paper-and-pencil survey was integrated into the Established Status Epilepticus Treatment Trial, a randomized trial of 3 treatments for benzodiazepine-refractory status epilepticus in pediatric and adult patients. Primary domains included attitudes toward trial enrollment, exception from informed consent, and community consultation. Simple descriptive statistics, χ², and Fisher’s exact tests were conducted.
Of 317 patients and surrogates, 90% agreed with or were neutral about the statement “I am glad that I/my family member was included in the Established Status Epilepticus Treatment Trial research study,” whereas 10% disagreed. Twenty-seven percent disagreed with enrollment in the study without prospective consent. Black participants were more likely than white, other race, and unknown-race participants to disagree with enrollment without prospective consent (36% versus 23%, 14%, and 14%, respectively). Participants indicated that patients (81%), their families (65%), and those at risk for seizures (51%) were most important to include in community consultation.
This study aimed to explore attitudes toward exception from informed consent enrollment among participants at all sites in a large, multicenter exception from informed consent trial. General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants. Our findings provide further support for targeted community consultation focusing on individuals with connections to the disease under study. Future research should focus on communication in the postenrollment period, especially with individuals who may have concerns about exception from informed consent.
Approaches to community consultation in exception from informed consent: Analysis of scope, efficiency, and cost at two centers
2018, Resuscitation
Community consultation (CC) is fundamental to the Exception from Informed Consent (EFIC) process for emergency research, designed to inform and receive feedback from the target study population about potential risks and benefits. To better understand the effectiveness of different techniques for CC, we evaluated EFIC processes at two centers participating in a trial of early cardiac catheterization following out-of-hospital cardiac arrest.
We studied the Institutional Review Board-approved CC activities at Maine Medical Center (MMC) and University of Arizona (AZ) in support of NCT02387398. In Maine, the public was consulted by survey at a professional basketball game and in the emergency department waiting room (in-person group), by multimedia direction to an online website (online group), and by mail (mailing group). Arizona respondents were either approached at a county fair (in-person group) or were directed to an online survey (online group) via social media advertising.
Among 2185 survey respondents, approval rates were high for community involvement and personal participation without individual consent. Community consultation using in-person, online, and mailed surveys offered slightly different approval rates, and the rate of responses by modality differed by age and education level but not ethnicity. Print advertising was the least cost effective at $442 per completed survey.
Canvassing at public events was the most efficient mode of performing CC, with approval rates similar to mailings, online surveys, and canvassing in other locations. Print advertisements in local papers had a low yield and cost more than other approaches.

View all citing articles on Scopus

: Please see page 163 for the Editor’s Capsule Summary of this article.

: Supervising editor: Melissa L. McCarthy, ScD

: Author contributions: AEF and NWD conceived of the study, read all abstracts and articles with potentially relevant content and selected articles for final analysis, read final article selections for data extraction, and drafted the article. AEF initially screened all articles. All authors participated in data analysis and contributed substantially to article revision. NWD takes responsibility for the paper as a whole.

: Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist and provided the following details: Dr. Dickert receives support from the Greenwall Foundation Faculty Scholars Program.

: A podcast for this article is available at www.annemergmed.com.

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Ethics/systematic review/meta-analysisLearning From Experience: A Systematic Review of Community Consultation Acceptance Data

Study objective

Methods

Results

Conclusion

Introduction

Editor’s Capsule Summary

Section snippets

Objective

General Results

Measured Attitudes Toward Exception From Informed Consent

Limitations

Discussion

J Clin Epidemiol

Resuscitation

Resuscitation

Circulation

Title 21 (Code of Federal Regulations), Part 50.24 Protection of Human Subjects

Getting the ethics right regarding research in the emergency setting: lessons from the PolyHeme study

Kennedy Inst Ethics J

Communicating with communities about emergency research

Acad Emerg Med

Community consultation for prehospital research: experiences of study coordinators and principal investigators

Prehosp Emerg Care

Studying community consultation in exception from informed consent trials

Crit Care Med

Does community consultation matter?

Acad Emerg Med

Ethics committee experience with emergency exception from informed consent protocols

J Empir Res Hum Res Ethics

Ethics/systematic review/meta-analysis
Learning From Experience: A Systematic Review of Community Consultation Acceptance Data